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AMNIOHOOK, plastic, 28 cm, sterile, s.u.

https://unicat.msf.org/cat/product/18987
STD SMSUAMNH28-

Valid Article

Former Code(s): -X
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
U1005 - Amniotic Membrane Perforators
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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AMNIOHOOK, disposable

Definition

Instrument ended by a hook used to rupture the amniotic membrane (amniotomy).

Synonym

amniotome

Specifications

Technical specifications

  • Polypropylene
  • Straight or curved rod, ended by a blunt hook
  • Length: 25 - 30 cm
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

Strictly for single use

To be ordered separately to complete the DELIVERY & EPISIOTOMY SET.

MSF requirements

This plastic model is less traumatic than the metal amniohook and reduces the risk of perforating the fontanel.

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